EP2194873B1 - Disposable diagnostic device - Google Patents
Disposable diagnostic device Download PDFInfo
- Publication number
- EP2194873B1 EP2194873B1 EP08803071A EP08803071A EP2194873B1 EP 2194873 B1 EP2194873 B1 EP 2194873B1 EP 08803071 A EP08803071 A EP 08803071A EP 08803071 A EP08803071 A EP 08803071A EP 2194873 B1 EP2194873 B1 EP 2194873B1
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- EP
- European Patent Office
- Prior art keywords
- disposable diagnostic
- part according
- diagnostic part
- sealing layer
- body fluid
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
- A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150274—Manufacture or production processes or steps for blood sampling devices
- A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150435—Specific design of proximal end
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
- A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15142—Devices intended for single use, i.e. disposable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15149—Arrangement of piercing elements relative to each other
- A61B5/15153—Multiple piercing elements stocked in a single compartment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
- A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
Definitions
- the invention relates to a diagnostic disposable part with a piercing element, which is designed for piercing into the skin and having a preferably laterally open collecting channel for receiving body fluid, and a detection element, the one with reagents, in particular enzymes, for the detection of an analyte in the body fluid provided test layer and is arranged in the collecting channel.
- the EP-A-0 365 196 discloses a disposable sensor element for insertion into a measuring instrument, wherein a water-soluble membrane is disposed between a tracer field and a reagent-dispensing field.
- the object of the invention is to further improve the sample collectors and methods for their production known in the prior art and to design them in such a way that unproblematic sample taking and reliable analyte detection are made possible.
- the invention is based on the idea of using disposable parts in which the sample can be biocompatible and reliably analyzed in a small volume as close as possible to the lancing device. Accordingly, it is proposed according to the invention that the detection element integrated in the collecting channel is provided with a sealing layer covering the reagents, the sealing layer being in the form of a liquid film and being soluble in the body fluid upon filling of the collecting channel, so that the analyte comes in contact with the reagents.
- the integrity of the test layer can also be improved during assembly and storage time, while at the same time ensuring that the test chemistry does not come into direct skin contact. Likewise, it can be ensured that no solid particles detach from the test layer provided with enzyme-rich dry substances and cause allergic reactions in the body.
- the dissolution time for dissolving the sealing layer in the body fluid is less than 10 s, preferably less than 2 s.
- the sealing layer encloses an edge of the detection element delimiting the test layer.
- the detection element has a carrier for the material layers applied without its own form, which may preferably be formed from a flat material.
- the test layer is located on the carrier and is provided on its side facing away from the carrier with the sealing layer.
- the piercing element consists of metal, in particular steel.
- test layer is provided with a substance also contained in the sealing layer.
- the detection element is firmly inserted into an end portion of the collecting channel, wherein the test layer is aligned in the lancing direction of the lancing element.
- the sealing layer is formed from nonionic surfactants.
- the lancing element is also conceivable that only a portion of the lancing element is provided with a coating formed from non-ionic surfactants, especially to improve the hydrophilicity and to create a surface optimized for blood uptake.
- the abrasion-resistant sealing layer it is possible for the abrasion-resistant sealing layer to cover a part of the lancing element which penetrates into the skin.
- polysorbates preferably polysorbate 20 and / or polysorbate 80.
- nonionic surfactants contain poloxamer, preferably poloxamer 188.
- nonionic surfactants at least one substance selected from the group fatty alcohol polyglycol ether, Glucamides, fatty alcohol ethoxylates, alkyl polyglycosides, sucrose fatty acid esters.
- the invention also relates to a magazine containing a plurality of diagnostic disposable parts according to the invention for use in a handheld device, in particular for blood glucose determination, and a system for the examination of a body fluid, in particular as a handheld device for blood sugar determination with at least one therein arranged or usable diagnostic disposable part.
- the puncturing element and / or the detection element is at least partially coated with nonionic surfactants as the coating material.
- This can be done favorably by applying the coating material in an at least predominantly anhydrous solvent, preferably ethanol, to the surface to be coated. The solvent may then be removed after coating by gas flow, vacuum and / or heating.
- the coating material is applied by dipping, spraying or contact coating on the surface to be coated. It may be advantageous if the viscosity of the coating material is adjusted by additional components.
- a further improvement provides that the detection element is cut from a flat material, and that the coating material is applied to the cut-to-size detection element before or after insertion into the lancing element.
- the detection element after coating on a support, in particular the front side is placed on a light guide, and that subsequently the mounting unit is composed of carrier and detection element with the lancing element.
- the diagnostic disposable parts 10 shown in the drawing can be used as a microfluidic sample collector or microsampler for determining blood sugar Insert in a trained handset 12, with a minimum amount of sample in the disposable part glucose detection is feasible.
- the microsampler 10 include a lancing element 14 with a slot-shaped, open on both sides collection channel 16 and a detection element 18 disposed therein for an optical or electrochemical measurement directly in the collection channel 16, one the detection element 18 and optionally also the lancing element 14 with a special Coating 20 is provided from non-ionic surfactants.
- a lancing element holder 22 and the detection element allow coupling with a lancing drive 24 for puncturing the skin 26 of, for example, a user's finger.
- the microsampler 10 can bring in an insertable into the device 12 magazine 28 successively in an active position of use.
- the active lancing element 14 has its tip 30 in the distal direction toward the body part 26, while a coupling end 32 of the holder 22 is coupled to the lancing drive 24 for a drive and signal coupling.
- the body fluid (blood or tissue fluid) received in the collecting channel 16 during the skin puncture can be examined directly by photometric or electrochemical means via the detection element 18, wherein the signal evaluation takes place in a device-side evaluation unit 34. It is also possible to display the measurement result on a display 36 for the user, so that a blood sugar control without complex handling steps on site is possible.
- the shaft-shaped elongated lancing element 14 has a transversely continuous longitudinal slot as a collecting channel 16. This allows, if appropriate by capillary action, the transfer of a microscopic amount of liquid onto the detection element 18 aligned in the direction of the tip 30.
- the elongate double-sided slot opening makes effective liquid absorption possible without the danger Constipation ensured by cell components.
- the volume of the collecting channel 16 is only a few 10 nanoliter.
- the lancing element 14 is clamped at its proximal end on the holder 22 provided with lateral grooves, so that the front side on the holder 22 applied detection element 18 engages in the collecting channel 16.
- the distal portion of the piercing member 14 made of steel is ground at an angle to the tip 30 to facilitate puncture into the skin by a reduced cross-section.
- Fig. 4 shows the constructed of several layers detection element 18 in an enlarged section.
- a transparent support 38 is provided, which sits on a holder 22 passing through light guide assembly 40.
- a test layer 42 which is provided with reagents for glucose detection in the blood collected in the collection channel 16 and possibly other excipients.
- the reagents can be formed by a per se known enzymatic system which reacts irreversibly with blood glucose with color change, but does not dissolve in the blood fluid. By scattering particles within the chemistry system, a device-side optical detection is made possible by backscattering of the measuring light irradiated via the light guide arrangement 40.
- the sealing layer 20 covers the test layer 42 and thus seals the reagents, so that initially a good storage stability is achieved and a detachment of reagent particles from the dry-stored test surface is avoided.
- the sealing also provides an important utility advantage in that direct skin contact with the test area or substances detached therefrom is prevented during puncture.
- the sealing layer 20 also encloses the side edges the test surface 42 to reliably exclude a detachment of particles. This is particularly important when the detection element 18 is formed by cutting from a large area coated film material.
- the sealing layer 20 is soluble when exposed to the inflowing into the collecting channel 16 blood fluid.
- the time required for sufficient dissolution, i. the time until receipt of an evaluable measurement signal should be less than 2 s in order not to restrict the ease of use. Accordingly, the sealant layer 20 should have a high hydrophilicity, whereby formation as a liquid film is advantageous.
- the sealant layer 20 should be biocompatible so as not to cause adverse reactions even on skin contact. This can be achieved particularly reliably by using pharmacologically and, if appropriate, food-chemically approved harmless substances as coating material. However, such substances should not have independent pharmacological functional properties within the scope of the pharmacological approval.
- the coating material must not affect the test reagents and the test procedure and thus the result, regardless of whether contact with the test surface takes place during production, storage or only during sample measurement.
- existing test chemistry should not only be compatible with the coating material, but should also suitably contain this material itself as the test surface 42.
- the test surface 42 as a wetting agent which is required anyway, for this purpose contain the substance which is also used as a sealing material. This avoids worrying concentration gradients or adverse changes in the overall system.
- a coating 20 'of the lancing element 14 may also prove to be advantageous in order to create a hydrophilic surface for receiving the body fluid, in particular in the region of the collecting channel 16. It is also conceivable, by a coating in the region of the tip 30, to reduce the friction during the puncture and thus the puncture pain.
- the consistency or viscosity of PS 20 can be optimized by adding other components.
- addition of poloxamer 188 (solid) could suitably modify the creep capability of the PS 20.
- polysorbate 80 has also been found to be a suitable coating material.
- the piercing element 14 and / or the detection element 18 is at least partially coated with nonionic surfactants as coating material.
- This can be done by applying the coating material by dipping, spraying or contact coating on the surface to be coated.
- the coating material is applied in ethanol as a solvent on the surface to be coated, and then the solvent removed, for example by a gas stream, negative pressure and / or heating.
- the detection element 18 can be fixed as a cut piece of flat material after the coating on the carrier 22, ie on the front side on the light guide 40, wherein then the mounting unit of carrier 22 and detection element 18 is joined to the lancing element 14. Further details can be found in the patent application PCT / US07 / 65918 to which reference is expressly made in this context.
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Abstract
Description
Die Erfindung betrifft ein diagnostisches Einmalteil mit einem Stechelement, das zum Einstechen in die Haut ausgebildet ist und einen vorzugsweise seitlich offenen Sammelkanal zum Aufnehmen von Körperflüssigkeit aufweist, und einem Nachweiselement, das eine mit Reagenzien, insbesondere Enzymen, für den Nachweis eines Analyten in der Körperflüssigkeit versehene Testschicht aufweist und in dem Sammelkanal angeordnet ist.The invention relates to a diagnostic disposable part with a piercing element, which is designed for piercing into the skin and having a preferably laterally open collecting channel for receiving body fluid, and a detection element, the one with reagents, in particular enzymes, for the detection of an analyte in the body fluid provided test layer and is arranged in the collecting channel.
Für Blutzucker-Selbstkontrollen bei Diabetikern ist es wünschenswert, der betroffenen Person möglichst wenige Handhabungsschritte aufzuerlegen und zugleich eine schmerzarme und zuverlässige Messung sicherzustellen. Dabei werden aus hygienischen Gründen Einmalartikel für einen Hauteinstich eingesetzt. Bei neueren Konzepten, wie sie beispielsweise in der
Die
Ausgehend hiervon liegt der Erfindung die Aufgabe zugrunde, die im Stand der Technik bekannten Probensammler und Verfahren zu deren Herstellung weiter zu verbessern und so zu gestalten, dass eine unproblematische Probenaufnahme und zuverlässige Analyterfassung ermöglicht wird.Proceeding from this, the object of the invention is to further improve the sample collectors and methods for their production known in the prior art and to design them in such a way that unproblematic sample taking and reliable analyte detection are made possible.
Zur Lösung dieser Aufgabe wird die im unabhängigen Patentanspruch angegebene Merkmalskombination vorgeschlagen. Vorteilhafte Ausgestaltungen und Weiterbildungen der Erfindung ergeben sich aus den abhängigen Ansprüchen.To solve this problem, the combination of features specified in the independent claim is proposed. Advantageous embodiments and modifications of the invention will become apparent from the dependent claims.
Die Erfindung geht von dem Gedanken aus, Einmalteile einzusetzen, bei denen die Probe in einem kleinen Volumen möglichst nahe am Stechorgan biokompatibel und zuverlässig analysiert werden kann. Dementsprechend wird erfindungsgemäß vorgeschlagen, dass das in dem Sammelkanal integrierte Nachweiselement mit einer auf der Testschicht aufgebrachten, die Reagenzien abdeckenden Versiegelungsschicht versehen ist, wobei die Versiegelungsschicht als Flüssigkeitsfilm bzw. fließfähiger Fluidfilm ausgebildet ist und bei Befüllung des Sammelkanals durch die Körperflüssigkeit löslich ist, so dass der Analyt in Kontakt mit den Reagenzien kommt. Dadurch kann die Integrität der Testschicht auch während des Zusammenbaus und der Lagerzeit verbessert werden, während zugleich gewährleistet ist, dass die Testchemie nicht in direkten Hautkontakt gelangt. Ebenso kann dadurch sichergestellt werden, dass sich keine Feststoffpartikel von der mit enzymbehafteten Trockensubstanzen versehenen Testschicht lösen und im Körper allergische Reaktionen auslösen. Dies ist angesichts der hohen Zahl und täglich erforderlichen Wiederholung der Anwendung von besonderer Bedeutung. Durch die Versiegelung ist es auch möglich, das Nachweiselement weiter nach distal in die Stechpartie zu verlagern, so dass auch das Sammelvolumen weiter reduziert werden kann. Wichtig ist dabei, dass die Messdauer nicht für den Anwender unzumutbar verlängert wird. Hierbei ist es vorteilhaft, wenn die Lösezeit zum Auflösen der Versiegelungsschicht in der Körperflüssigkeit weniger als 10 s, vorzugsweise weniger als 2 s beträgt.The invention is based on the idea of using disposable parts in which the sample can be biocompatible and reliably analyzed in a small volume as close as possible to the lancing device. Accordingly, it is proposed according to the invention that the detection element integrated in the collecting channel is provided with a sealing layer covering the reagents, the sealing layer being in the form of a liquid film and being soluble in the body fluid upon filling of the collecting channel, so that the analyte comes in contact with the reagents. Thereby, the integrity of the test layer can also be improved during assembly and storage time, while at the same time ensuring that the test chemistry does not come into direct skin contact. Likewise, it can be ensured that no solid particles detach from the test layer provided with enzyme-rich dry substances and cause allergic reactions in the body. This is of particular importance given the high number and repetition of daily use required. Due to the sealing, it is also possible to shift the detection element further distally into the lancing section, so that the collecting volume can be further reduced. It is important that the measurement time is not extended unreasonably for the user. In this case, it is advantageous if the dissolution time for dissolving the sealing layer in the body fluid is less than 10 s, preferably less than 2 s.
Zur weiteren Verbesserung des Schutzes gegen Ablösen von Partikeln ist es von besonderem Vorteil, wenn die Versiegelungsschicht einen die Testschicht begrenzenden Rand des Nachweiselements umschließt.To further improve the protection against detachment of particles, it is of particular advantage if the sealing layer encloses an edge of the detection element delimiting the test layer.
In baulich vorteilhafter Ausgestaltung weist das Nachweiselement einen Träger für die ohne eigene Form aufgebrachten Materialschichten auf, der bevorzugt aus einem Flachmaterial gebildet sein kann. Die Testschicht befindet sich dabei auf dem Träger und ist an ihrer von dem Träger abgewandten Seite mit der Versiegelungsschicht versehen.In a structurally advantageous embodiment, the detection element has a carrier for the material layers applied without its own form, which may preferably be formed from a flat material. The test layer is located on the carrier and is provided on its side facing away from the carrier with the sealing layer.
Vorteilhaft ist es auch, wenn das Stechelement aus Metall, insbesondere Stahl besteht.It is also advantageous if the piercing element consists of metal, in particular steel.
Um die Testeigenschaften möglichst nicht zu beeinflussen und die Schichtanpassung zu optimieren, ist es vorteilhaft, wenn die Testschicht mit einer auch in der Versiegelungsschicht enthaltenen Substanz versehen ist.In order not to influence the test properties as much as possible and to optimize the layer adaptation, it is advantageous if the test layer is provided with a substance also contained in the sealing layer.
Für die Beaufschlagung mit der beim Einstich gewonnenen Körperflüssigkeit ist es von Vorteil, wenn das Nachweiselement in einen Endabschnitt des Sammelkanals fest eingesetzt ist, wobei die Testschicht in Stechrichtung des Stechelements ausgerichtet ist.For the application of the body fluid obtained in the puncture, it is advantageous if the detection element is firmly inserted into an end portion of the collecting channel, wherein the test layer is aligned in the lancing direction of the lancing element.
Ein besonderer Aspekt der Erfindung liegt darin, dass die Versiegelungsschicht aus nicht-ionischen Tensiden gebildet ist. In diesem Zusammenhang ist es auch denkbar, dass nur eine Partie des Stechelements mit einer aus nicht-ionischen Tensiden gebildeten Beschichtung versehen ist, vor allem um die Hydrophilie zu verbessern und eine für die Blutaufnahme optimierte Oberfläche zu schaffen. Hierbei ist es möglich, dass die abriebfeste Versiegelungsschicht eine in die Haut eindringende Partie des Stechelements bedeckt.A particular aspect of the invention is that the sealing layer is formed from nonionic surfactants. In this context, it is also conceivable that only a portion of the lancing element is provided with a coating formed from non-ionic surfactants, especially to improve the hydrophilicity and to create a surface optimized for blood uptake. In this case, it is possible for the abrasion-resistant sealing layer to cover a part of the lancing element which penetrates into the skin.
Besonders bevorzugt kommen Polysorbate, vorzugsweise Polysorbat 20 und/oder Polysorbat 80 zum Einsatz. Denkbar ist es auch, dass die nicht-ionischen Tenside Poloxamer, vorzugsweise Poloxamer 188 enthalten.Particular preference is given to using polysorbates, preferably
Eine weitere vorteilhafte Ausgestaltung sieht vor, dass die nicht-ionischen Tenside mindestens eine Substanz ausgewählt aus der Gruppe Fettalkohol-Polyglycol-Ether, Glucamide, Fettalkohol-Ethoxylate, Alkyl-Poly-Glycoside, Saccharose-Fettsäure-Ester enthalten.A further advantageous embodiment provides that the nonionic surfactants at least one substance selected from the group fatty alcohol polyglycol ether, Glucamides, fatty alcohol ethoxylates, alkyl polyglycosides, sucrose fatty acid esters.
Gegenstand der Erfindung ist auch ein Magazin enthaltend eine Mehrzahl von erfindungsgemäßen diagnostischen Einmalteilen für den Einsatz in einem Handgerät insbesondere zur Blutzuckerbestimmung, sowie ein System für die Untersuchung einer Körperflüssigkeit, insbesondere als Handgerät zur Blutzuckerbestimmung mit mindestens einem darin angeordneten oder einsetzbaren erfindungsgemäßen diagnostischen Einmalteil.The invention also relates to a magazine containing a plurality of diagnostic disposable parts according to the invention for use in a handheld device, in particular for blood glucose determination, and a system for the examination of a body fluid, in particular as a handheld device for blood sugar determination with at least one therein arranged or usable diagnostic disposable part.
In verfahrensmäßiger Hinsicht ist es vorteilhaft, wenn das Stechelement und/oder das Nachweiselement mit nicht-ionischen Tensiden als Beschichtungsmaterial zumindest partiell beschichtet wird. Dies lässt sich dadurch günstig bewerkstelligen, dass das Beschichtungsmaterial in einem zumindest überwiegend wasserfreien Lösemittel, vorzugsweise Ethanol auf die zu beschichtende Oberfläche aufgebracht wird. Das Lösemittel kann sodann nach dem Beschichten durch einen Gasstrom, Unterdruck und/oder Erwärmen entfernt werden.In terms of the method, it is advantageous if the puncturing element and / or the detection element is at least partially coated with nonionic surfactants as the coating material. This can be done favorably by applying the coating material in an at least predominantly anhydrous solvent, preferably ethanol, to the surface to be coated. The solvent may then be removed after coating by gas flow, vacuum and / or heating.
Vorteilhafterweise wird das Beschichtungsmaterial durch Tauch-, Sprüh- oder Kontaktbeschichten auf die zu beschichtende Oberfläche aufgebracht. Hierbei kann es von Vorteil sein, wenn die Viskosität des Beschichtungsmaterials durch Zusatzkomponenten eingestellt wird.Advantageously, the coating material is applied by dipping, spraying or contact coating on the surface to be coated. It may be advantageous if the viscosity of the coating material is adjusted by additional components.
Eine weitere Verbesserung sieht vor, dass das Nachweiselement aus einem Flachmaterial zugeschnitten wird, und dass das Beschichtungsmaterial auf das zugeschnittene Nachweiselement vor oder nach dem Einsetzen in das Stechelement aufgebracht wird.A further improvement provides that the detection element is cut from a flat material, and that the coating material is applied to the cut-to-size detection element before or after insertion into the lancing element.
Herstellungstechnisch ist es auch von Vorteil, wenn das Nachweiselement nach dem Beschichten auf einen Träger, insbesondere stirnseitig auf einen Lichtleiter aufgesetzt wird, und dass anschließend die Montageeinheit aus Träger und Nachweiselement mit dem Stechelement zusammengesetzt wird.Manufacturing technology, it is also advantageous if the detection element after coating on a support, in particular the front side is placed on a light guide, and that subsequently the mounting unit is composed of carrier and detection element with the lancing element.
Zur Einstellung der Viskosität des Beschichtungsmaterials ist es denkbar, ein flüssiges Tensid mit einem anderen nicht-ionischen (ggf. auch festen) Tensid zu kombinieren, solange die resultierende Mischung nur irgendwie nicht-kristallin bzw. fließfähig ist.To adjust the viscosity of the coating material, it is conceivable to combine a liquid surfactant with another nonionic (or solid) surfactant, as long as the resulting mixture is only somehow non-crystalline or flowable.
Im Folgenden wird die Erfindung anhand eines in der Zeichnung schematisch dargestellten Ausführungsbeispiels näher erläutert. Es zeigen:
- Fig. 1
- ein Blutzuckermessgerät mit einem darin eingesetzten Micro- sampler als diagnostisches Einmalteil in einer schaubildlichen Darstellung;
- Fig. 2
- den Microsampler in der Draufsicht; einer abgebrochenen per- spektivischen Darstellung;
- Fig. 3
- den Microsampler in einer abgebrochenen Seitenansicht;
- Fig. 4
- einen vergrößerten Ausschnitt aus
Fig. 2 .
- Fig. 1
- a blood glucose meter with a microsampler inserted therein as a diagnostic disposable part in a diagrammatic representation;
- Fig. 2
- the microsampler in plan view; a broken perspective view;
- Fig. 3
- the microsampler in a broken side view;
- Fig. 4
- an enlarged section
Fig. 2 ,
Die in der Zeichnung dargestellten diagnostischen Einmalteile 10 lassen sich als mikrofluidische Probensammler bzw. Microsampler zur Blutzuckerbestimmung in einem dafür ausgebildeten Handgerät 12 einsetzen, wobei mit einer minimalen Probenmenge in dem Einmalteil ein Glucosenachweis durchführbar ist. Zu diesem Zweck umfassen die Microsampler 10 ein Stechelement 14 mit einem schlitzförmigen, beidseitig offenen Sammelkanal 16 und ein darin angeordnetes Nachweiselement 18 für eine optische oder elektrochemische Messung direkt in dem Sammelkanal 16, wobei eine das Nachweiselement 18 und gegebenenfalls auch das Stechelement 14 mit einer speziellen Beschichtung 20 aus nicht-ionischen Tensiden versehen ist. Ein Halter 22 für das Stechelement und das Nachweiselement ermöglicht eine Kopplung mit einem Stechantrieb 24 für einen Einstich in die Haut 26 beispielsweise eines Fingers eines Benutzers.The diagnostic
Wie in
Wie aus
In der Seitenansicht gemäß
Die Versiegelungsschicht 20 überdeckt die Testschicht 42 und versiegelt damit die Reagenzien, so dass zunächst eine gute Lagerstabilität erreicht und ein Ablösen von Reagenzpartikeln von der trockengelagerten Testfläche vermieden wird. Durch die Versiegelung ergibt sich auch ein wichtiger Gebrauchsvorteil dahingehend, dass ein direkter Hautkontakt mit der Testfläche oder davon abgelösten Substanzen beim Einstich verhindert wird. Zweckmäßig umschließt die Versiegelungsschicht 20 auch die Seitenränder der Testfläche 42, um ein Ablösen von Teilchen zuverlässig auszuschließen. Dies ist besonders dann wichtig, wenn das Nachweiselement 18 durch Zuschneiden aus einem großflächigen beschichteten Folienmaterial gebildet ist.The
Um den Nachweis des Analyten nicht wesentlich zu behindern, ist die Versiegelungsschicht 20 bei Beaufschlagung mit der in den Sammelkanal 16 einströmenden Blutflüssigkeit löslich. Die erforderliche Zeit für ein hinreichendes Auflösen, d.h. die Zeit bis zum Erhalt eines auswertbaren Messsignals sollte weniger als 2 s betragen, um den Benutzungskomfort nicht einzuschränken. Entsprechend sollte die Versiegelungsschicht 20 eine hohe Hydrophilie besitzen, wobei eine Ausbildung als Flüssigkeitsfilm vorteilhaft ist.In order not to hinder the detection of the analyte substantially, the
Es versteht sich, dass die Versiegelungsschicht 20 biokompatibel sein sollte, um nicht selbst bei einem Hautkontakt nachteilige Reaktionen auszulösen. Dies lässt sich besonders zuverlässig dadurch erreichen, dass pharmakologisch und ggf. auch lebensmittelchemisch zugelassene unbedenkliche Substanzen als Beschichtungsmaterial eingesetzt werden. Solche Substanzen sollen aber im Rahmen der pharmakologischen Zulassung keine eigenständigen pharmakologischen funktionalen Eigenschaften haben.It will be understood that the
Schließlich darf das Beschichtungsmaterial die Testreagenzien und den Testablauf und damit das Ergebnis nicht beeinflussen, gleichgültig ob ein Kontakt mit der Testfläche bei der Herstellung, Lagerung oder erst bei der Probenmessung stattfindet. Idealerweise sollte eine bestehende Testchemie nicht nur hinsichtlich des Beschichtungsmaterials verträglich sein, sondern als Testfläche 42 dieses Material zweckmäßig auch selbst enthalten. So kann die Testfläche 42 als Benetzungsmittel, welches ohnehin benötigt wird, hierfür diejenige Substanz enthalten, welche auch als Versiegelungsmaterial eingesetzt wird. Damit lassen sich bedenklichen Konzentrationsgradienten oder nachteilige Veränderungen im Gesamtsystem vermeiden.Finally, the coating material must not affect the test reagents and the test procedure and thus the result, regardless of whether contact with the test surface takes place during production, storage or only during sample measurement. Ideally, existing test chemistry should not only be compatible with the coating material, but should also suitably contain this material itself as the
Eine Beschichtung 20' des Stechelements 14 mit kann sich ebenfalls als vorteilhaft erweisen, um eine hydrophile Oberfläche für die Aufnahme der Körperflüssigkeit insbesondere im Bereich des Sammelkanals 16 zu schaffen. Denkbar ist es auch, durch eine Beschichtung im Bereich der Spitze 30 die Reibung beim Einstich und damit den Stechschmerz zu verringern.A coating 20 'of the lancing
In diesem Zusammenhang haben sich nicht-ionische Tenside und vor allem Polysorbate als besonders geeignetes Beschichtungsmaterial erwiesen, um die vorgenannten Anforderungen zu erfüllen und eine Massenherstellung von Einmalartikeln praktischerweise zu ermöglichen. Besonders bevorzugt wird Polysorbat 20 (PS 20) eingesetzt, welches die folgenden Vorteile aufweist:
PS 20 wird in Medikamenten (Injektions-Lösungen) verwendet und ist auch in Nahrungsmitteln zu finden.PS 20 lässt sich lange lagern und wirkt auch noch lange nach Verfallsdatum.PS 20 ist hochmolekular, diffundiert also kaum durch Körpergewebe;PS 20 ist bei Raumtemperatur dick-flüssig und löst sich gut im Lösemittel Ethanol (und nicht nur in Wasser).PS 20 im Lösemittel Ethanol ist steril, verkeimt nicht und entkeimt benetzte Bereiche durch das Lösemittel.PS 20 lässt sich in ethanolischer Lösung leicht auftragen und dringt wegen der geringen Lösemittel-Viskosität in kapillare Strukturen rasch und gut ein.PS 20, aufgetragen aus Ethanol, lässt sich rasch und zuverlässig von diesem befreien (z.B. durch Luftstrom, Unterdruck)PS 20 bildet kein Kristallgitter und löst sich folglich bei Kontakt mit dem Wasser der Probe (Blut) rasch auf, da keine hohe Lösungsenthalpie zur Überwindung von Gitterkräften erforderlich ist. Eine rasche Interaktion mit der Probe führt auch zu rascher Benetzung.PS 20, kriecht auch (mengenabhängig) nach dem Trocknen in feinste Strukturen. Die Hydrophilie und Benetzungsgeschwindigkeit scheint nach einiger Zeit des Lagerns noch besser - und nicht schlechter - zu werden.PS 20 zeigte in ersten Experimenten keine erkennbare Beeinflussung der Nachweisreaktion.PS 20 sollte eine geringe, aber nicht funktionale Gerinnungshemmung bewirken (und zwar nur in dem Sammelkanal, während außerhalb davon die Verdünnung zu hoch ist).
-
PS 20 is used in medicines (injection solutions) and can also be found in foods. -
PS 20 can be stored for a long time and works long after the expiration date. -
PS 20 is high molecular weight, so it hardly diffuses through body tissue; -
PS 20 is thick-liquid at room temperature and dissolves well in the solvent ethanol (and not only in water). -
PS 20 in solvent Ethanol is sterile, does not germinate and sterilizes wetted areas by the solvent. -
PS 20 is easy to apply in ethanolic solution and penetrates quickly and well due to the low solvent viscosity in capillary structures. -
PS 20, applied from ethanol, can be quickly and reliably freed of this (eg by air flow, negative pressure) -
PS 20 does not form a crystal lattice and consequently dissolves rapidly upon contact with the water of the sample (blood) because there is no high enthalpy of solution To overcome lattice forces is required. Rapid interaction with the sample also results in rapid wetting. -
PS 20, also creeps (depending on quantity) after drying in the finest structures. The hydrophilicity and wetting speed seems to become even better after some storage time - and not worse.-
PS 20 showed no noticeable influence on the detection reaction in the first experiments. -
PS 20 should cause a slight but non-functional anticoagulation (only in the collection channel, while outside the dilution is too high).
-
Die Konsistenz bzw. Viskosität von PS 20 lässt sich ggf. durch Zusatz anderer Komponenten optimieren. Beispielsweise könnte eine Zugabe von Poloxamer 188 (fest) die Kriechfähigkeit des PS 20 geeignet modifizieren. Weiterhin hat sich auch Polysorbat 80 als geeignetes Beschichtungsmaterial herausgestellt.If necessary, the consistency or viscosity of
Weitere denkbare Stoffklassen, die zwar körperfremd, jedoch in der Lebensmittelchemie und Biochemie bzw. Molekularbiologie zum Einsatz kommen, sind folgende Detergenzien:
Selbstverständlich sind auch Kombinationen dieser Substanzen untereinander oder mit anderen Substanzen denkbar.Of course, combinations of these substances with each other or with other substances are conceivable.
Bei der Herstellung von diagnostischen Einmalartikeln 10 ist es also vorteilhaft, wenn das Stechelement 14 und/oder das Nachweiselement 18 mit nicht-ionischen Tensiden als Beschichtungsmaterial zumindest partiell beschichtet wird. Dies kann dadurch erfolgen, dass das Beschichtungsmaterial durch Tauch-, Sprüh- oder Kontaktbeschichten auf die zu beschichtende Oberfläche aufgebracht wird. Zweckmäßig wird das Beschichtungsmaterial in Ethanol als Lösemittel auf die zu beschichtende Oberfläche aufgebracht wird, und anschließend das Lösemittel entfernt, beispielsweise durch einen Gasstrom, Unterdruck und/oder Erwärmen.In the production of diagnostic
Das Nachweiselement 18 kann als zugeschnittenes Flachmaterialstück nach dem Beschichten auf dem Träger 22, d.h. stirnseitig auf dem Lichtleiter 40 fixiert werden, wobei anschließend die Montageeinheit aus Träger 22 und Nachweiselement 18 mit dem Stechelement 14 zusammengefügt wird. Weitere Einzelheiten hierzu ergeben sich aus der Patentanmeldung
Claims (15)
- Disposable diagnostic part comprising a lancing element (14) which is designed for puncturing the skin (26) and has a preferably laterally open collecting channel (16) for taking up body fluid, and comprising a detection element (18) which has a test layer (42) provided with reagents and in particular enzymes for the detection of an analyte in the body fluid and is disposed in the collecting channel (16), characterized in that the detection element (18) is provided with a sealing layer (20) which is applied to the test layer (42) and covers the reagents, wherein the sealing layer (20) is in the form of a liquid film and is dissolvable when the collecting channel (16) is filled by body fluid so that the analyte comes into contact with the reagents.
- Disposable diagnostic part according to claim 1, characterized in that the time required to dissolve the sealing layer (20) in the body fluid is less than 10 s, preferably less than 2 s.
- Disposable diagnostic part according to claim 1 or 2, characterized in that the sealing layer (20) encloses a margin of the detection element (18) which borders the test layer (42).
- Disposable diagnostic part according to one of the claims 1 to 3, characterized in that the detection element (18) has a support (38) formed from a flat material.
- Disposable diagnostic part according to one of the claims 1 to 4, characterized in that the lancing element (14) consists of metal, in particular of steel.
- Disposable diagnostic part according to one of the claims 1 to 5, characterized in that the test layer (42) is provided with a substance that is also present in the sealing layer (20).
- Disposable diagnostic part according to one of the claims 1 to 6, characterized in that the detection element (18) is firmly inserted into an end section of the collecting channel (16) and the test layer (42) is aligned in the lancing direction of the lancing element (14).
- Disposable diagnostic part according to one of the claims 1 to 7, characterized in that the sealing layer (20) is formed from non-ionic surfactants.
- Disposable diagnostic part according to claim 8, characterized in that the non-ionic surfactants contain a polysorbate, preferably polysorbate 20 and/or polysorbate 80.
- Disposable diagnostic part according to one of the claims 8 or 9, characterized in that the non-ionic surfactants contain poloxamer, preferably poloxamer 188.
- Disposable diagnostic part according to one of the claims 8 to 10, characterized in that the non-ionic surfactants contain at least one substance selected from the group comprising fatty alcohol polyglycol ethers, glucamides, fatty alcohol ethoxylates, alkyl-polyglycosides, sucrose fatty acid esters.
- Disposable diagnostic part according to one of the claims 1 to 11, characterized in that the sealing layer (20) covers a part of the lancing element (14) which penetrates into the skin (26).
- Disposable diagnostic part according to one of the claims 1 to 12, characterized in that the sealing layer (20) forms a hydrophilic surface for the uptake of body fluid during skin (26) puncture.
- Magazine (28) containing a plurality of disposable diagnostic parts (10) according to one of the previous claims for use in a hand-held device (12) especially for the determination of blood sugar.
- System for analysing a body fluid in particular as a hand-held device for determining blood sugar comprising at least one disposable diagnostic part (10) according to one of the claims 1 to 13.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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EP08803071A EP2194873B1 (en) | 2007-08-16 | 2008-08-15 | Disposable diagnostic device |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07114414A EP2025287A1 (en) | 2007-08-16 | 2007-08-16 | Diagnostic disposable part and method for its production |
EP08803071A EP2194873B1 (en) | 2007-08-16 | 2008-08-15 | Disposable diagnostic device |
PCT/EP2008/060780 WO2009022018A1 (en) | 2007-08-16 | 2008-08-15 | Disposable diagnostic part and a method for the manufacture thereof |
Publications (2)
Publication Number | Publication Date |
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EP2194873A1 EP2194873A1 (en) | 2010-06-16 |
EP2194873B1 true EP2194873B1 (en) | 2011-03-02 |
Family
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EP07114414A Withdrawn EP2025287A1 (en) | 2007-08-16 | 2007-08-16 | Diagnostic disposable part and method for its production |
EP08803071A Not-in-force EP2194873B1 (en) | 2007-08-16 | 2008-08-15 | Disposable diagnostic device |
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EP07114414A Withdrawn EP2025287A1 (en) | 2007-08-16 | 2007-08-16 | Diagnostic disposable part and method for its production |
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US (1) | US8858466B2 (en) |
EP (2) | EP2025287A1 (en) |
AT (1) | ATE499877T1 (en) |
DE (1) | DE502008002764D1 (en) |
WO (1) | WO2009022018A1 (en) |
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CA2625857C (en) * | 2005-10-15 | 2013-05-28 | F. Hoffmann-La Roche Ag | Test element and test system for examining a body fluid |
US7766846B2 (en) | 2008-01-28 | 2010-08-03 | Roche Diagnostics Operations, Inc. | Rapid blood expression and sampling |
EP2248463A1 (en) * | 2009-05-09 | 2010-11-10 | F. Hoffmann-La Roche AG | Test unit for use in a test device and test system |
TWI532468B (en) | 2011-03-22 | 2016-05-11 | 福 赫夫曼 拉瑞奇股份有限公司 | Analytical aid with hydrophilic coating containing nanoparticles with silica structure |
EP3300663B1 (en) * | 2016-09-28 | 2019-11-20 | Roche Diabetes Care GmbH | Sampling device and system for collecting a sample of a body fluid |
CN112843448B (en) * | 2020-12-23 | 2022-07-22 | 河南理工大学 | Anti osteoporosis medicine screening kit |
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US5108889A (en) * | 1988-10-12 | 1992-04-28 | Thorne, Smith, Astill Technologies, Inc. | Assay for determining analyte using mercury release followed by detection via interaction with aluminum |
US6612111B1 (en) * | 2000-03-27 | 2003-09-02 | Lifescan, Inc. | Method and device for sampling and analyzing interstitial fluid and whole blood samples |
US6837988B2 (en) * | 2001-06-12 | 2005-01-04 | Lifescan, Inc. | Biological fluid sampling and analyte measurement devices and methods |
US6875613B2 (en) * | 2001-06-12 | 2005-04-05 | Lifescan, Inc. | Biological fluid constituent sampling and measurement devices and methods |
DE10134650B4 (en) * | 2001-07-20 | 2009-12-03 | Roche Diagnostics Gmbh | System for taking small amounts of body fluid |
US20030116447A1 (en) * | 2001-11-16 | 2003-06-26 | Surridge Nigel A. | Electrodes, methods, apparatuses comprising micro-electrode arrays |
US20030143113A2 (en) * | 2002-05-09 | 2003-07-31 | Lifescan, Inc. | Physiological sample collection devices and methods of using the same |
US20040193202A1 (en) * | 2003-03-28 | 2004-09-30 | Allen John J. | Integrated lance and strip for analyte measurement |
CA2558086C (en) * | 2004-03-06 | 2013-02-26 | F. Hoffmann-La Roche Ag | Body fluid sampling device |
EP1627684A1 (en) * | 2004-08-20 | 2006-02-22 | F. Hoffmann-La Roche Ag | Microfluidic system and method of producing the same |
US7488298B2 (en) * | 2004-10-08 | 2009-02-10 | Roche Diagnostics Operations, Inc. | Integrated lancing test strip with capillary transfer sheet |
US7803319B2 (en) * | 2005-04-29 | 2010-09-28 | Kimberly-Clark Worldwide, Inc. | Metering technique for lateral flow assay devices |
CA2625857C (en) * | 2005-10-15 | 2013-05-28 | F. Hoffmann-La Roche Ag | Test element and test system for examining a body fluid |
ATE476140T1 (en) | 2006-10-15 | 2010-08-15 | Hoffmann La Roche | DIAGNOSTIC TEST ELEMENT AND METHOD FOR PRODUCING IT |
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2007
- 2007-08-16 EP EP07114414A patent/EP2025287A1/en not_active Withdrawn
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- 2008-08-15 AT AT08803071T patent/ATE499877T1/en active
- 2008-08-15 EP EP08803071A patent/EP2194873B1/en not_active Not-in-force
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EP2025287A1 (en) | 2009-02-18 |
US8858466B2 (en) | 2014-10-14 |
US20100168617A1 (en) | 2010-07-01 |
WO2009022018A1 (en) | 2009-02-19 |
EP2194873A1 (en) | 2010-06-16 |
DE502008002764D1 (en) | 2011-04-14 |
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